The most complete summary of innovative drugs and first generic drugs approved by FDA in 2019: 38 NDA, 10 bla, 96 first generic drugs, 24 CBER approvals

Author: in 2019, the FDA's Center for drug evaluation and Research (CDER) approved 48 NDA and Bla applications, as well as 96 first generic drugs; 37 new molecular entities, 21 orphan drugs and 24 drugs in 48 first NDA and Bla applications received priority review According to the FDA safety and innovation act (gain), the new antibiotics fetroja (for complex urinary tract infections), xenleta (for community acquired bacterial pneumonia), antituberculous drugs pretomanid, zerbaxa (for hospital acquired bacterial pneumonia and ventilator-related bacterial pneumonia) and recarbrio (imipenem, cilastatin and relebactam combined injection) were used for treatment Adult complicated urinary tract infection and complicated abdominal infection) was awarded the title of qualified infectious disease product (qidp) by FDA The global alliance for TB drug development, which developed pretomanid, also received a tropical priority review certificate Vyondys53, the first targeted treatment for DMD rare disease, was given priority review and orphan drug designation by FDA In addition, FDA awarded development company Sarepta therapeutics Inc a priority review certificate for rare pediatric diseases Because of the benefits of trikafta, a new cystic fibrosis drug, to a large number of patients with cystic fibrosis, the FDA granted trikafta all available designations, including priority review, fast track, breakthrough treatment and orphan drugs, which promoted the approval in the most effective way It took three months to complete the approval, nearly five months in advance At the same time, the FDA awarded vertex a priority review voucher for rare pediatric diseases Genentech's rozlytrek (entretinib) is the third FDA approved cancer treatment based on the common biomarker of different types of tumors rather than the tumor origin The approval marks a new model for cancer drug development, "tissueagnostic." The other two drugs are pembrolizumab in 2017 for the treatment of microsatellite unstable high (MSI-H) or mismatch repair defect (dmmr) tumors, and larotretinib in 2018 for the treatment of ntrk gene fusion tumors Novartis' piqray (alpelisib) is the first PI3K inhibitor for breast cancer and the first new molecular entity approved under the RTOR pilot program RTOR allows FDA to start analyzing key efficacy and safety data sets prior to formal application submission, and allows review teams to start reviewing and communicating with applicants earlier Piqray also uses the latest assessment aid (AAID), a multidisciplinary review template designed to focus FDA written reviews on critical thinking and consistency and reduce the time spent on administrative tasks Piqray was approved about three months ahead of the PDUFA target date The first oral GLP-1 drug, rybelsu somaluptide oral tablet of Novo Nordisk, was approved This is the first drug for the treatment of glucagon like peptide (GLP-1) receptor agonist without injection, which is used for the non insulin treatment of type 2 diabetic patients And Eli Lilly's baqsimi nasal powder inhaler is the first approved glucagon therapy that can be used for emergency treatment of severe hypoglycemia without injection Figure 1, number of new drugs approved by CDER in 2010-2019 Figure 2, number of first generic drugs approved by CDER in 2010-2019 FDA issued competitive generic therapeutics (CGT) in February 2019, which aims to encourage pharmaceutical enterprises to develop generic drugs with insufficient competition through policy support According to the FDA reauthorization Act issued in 2017, if there is no more than one approved drug in the FDA "orange peel book", the drug will be considered as insufficient generic competition, and the generic application submitted for such drugs can obtain CGT qualification In Table 1, 48 NDA and Bla applications in 2019, FDA's Center for biological product evaluation and Research (CBER) approved 21 BLA applications, 3 NDA and anda applications Among them, there are three vaccine products (the first active vaccine against smallpox and monkeypox, the first vaccine against Ebola virus and dengue tetravalent live vaccine), and gene therapy zolgensma The first vaccine to prevent Ebola virus was given priority review and breakthrough therapy by FDA The safety and effectiveness of the vaccine was evaluated in less than six months, and a tropical disease priority review certificate was awarded to Merck, which developed the vaccine Form II, 20 BLA applications form III, 3 NDA and anda applications